FDA Grants Opdivo New Breakthrough Therapy Status

The new Breakthrough Designation is the fifth granted for Opdivo

Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Opdivo (nivolumab), to potentially treat recurrent or metastic squamous cell carcinoma of the head and neck (SCCHN) after platinum based therapy. This is the fifth Breakthrough status the FDA has granted Opdivo.

The new designation is supported by the ‘CheckMate -141' Phase 3, open-label, randomized trial. The trial evaluated Opdivo vs. investigator's choice of therapy in patients with recurrent or metastatic SCCHN with tumor progression within 6 months of platinum therapies in the adjuvant, primary, recurrent or metastatic setting.